FDA Product Code
FDA Product Code HMX — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.4350
510(k) Clearances — 77 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K010305 | WEISS RETINAL CANNULA | Micron Surgical, Inc. | 2001-05-02 | Traditional | PDF ↗ |
| K000457 | VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES | Retinalabs.Com | 2000-05-09 | Traditional | PDF ↗ |
| K970873 | ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.) | American Medical Devices, Inc. | 1997-05-20 | Traditional | PDF ↗ |
| K943932 | STERISEAL OPHTHALMIC CANNULA | Pharma-Plast, Ltd. | 1995-01-18 | Traditional | PDF ↗ |
| K942403 | INFUSION CANNULA | Microsurgical Technology, Inc. | 1994-08-17 | Traditional | PDF ↗ |
| K934844 | INTER TIP T | Microsurgical Technology, Inc. | 1994-04-19 | Traditional | PDF ↗ |
| K930113 | KIRWAN IRRIGATION/ASPIRATION HANDPIECE | Kirwan Surgical Products, Inc. | 1994-02-17 | Traditional | PDF ↗ |
| K921488 | ASPIRATING ENDO OCULAR PROBE W/ILLUMINATION | Surgical Technologies, Inc. | 1992-05-07 | Traditional | PDF ↗ |
| K915074 | IRRIGATOR/ASPIRATOR PROBE | Biomedical Dynamics, Inc. | 1992-02-05 | Traditional | PDF ↗ |
| K904074 | VITREORETINAL INFUSION CANNULA | Visitec Co. | 1991-02-26 | Traditional | PDF ↗ |
| K901618 | OCULAR INFUSION CANNULA SYSTEM | Tamcenan Corp. | 1990-05-31 | Traditional | PDF ↗ |
| K890782 | GRIESHABER SOFT TIP NEEDLE (20 & 19 GAUGES) | Grieshaber & Co. | 1989-06-23 | Traditional | PDF ↗ |
| K882884 | STORZ INFUSION CANNULA | Storz Instrument Co. | 1988-08-04 | Traditional | PDF ↗ |
| K880347 | ANESTHESIA/RETROBULBAR NEEDLES | Myocure, Inc. | 1988-05-03 | Traditional | PDF ↗ |
| K875030 | OCU-1 | Rudolph Beaver, Inc. | 1988-05-03 | Traditional | PDF ↗ |
| K880346 | CANNULAS | Myocure, Inc. | 1988-05-03 | Traditional | PDF ↗ |
| K881487 | OPHTHALMIC CANNULA | Surgical Instrument, Inc. | 1988-04-29 | Traditional | PDF ↗ |
| K874992 | PRISMA DISPOSABLE IRRIGATING LENS DIALER | Advanced Surgical Products, Inc. | 1988-04-13 | Traditional | PDF ↗ |
| K874972 | PRISMA DISPOS. BISHOP-HARMON IRRIGATING CANNULA | Advanced Surgical Products, Inc. | 1988-04-13 | Traditional | PDF ↗ |
| K874996 | PRISMA DISPOSABLE KUGLEN IRRIGATING LENS MANIPULA. | Advanced Surgical Products, Inc. | 1988-04-13 | Traditional | PDF ↗ |
| K874969 | PRISMA DISPOSABLE KRATZ CAPSULE POLISHER | Advanced Surgical Products, Inc. | 1988-04-13 | Traditional | PDF ↗ |
| K875002 | PRISMA DISPOSABLE VISCOELASTIC I/A CANNULA | Advanced Surgical Products, Inc. | 1988-04-13 | Traditional | PDF ↗ |
| K874977 | PRISMA DISPOSABLE DOUBLE I/A CANNULA CLOSED | Advanced Surgical Products, Inc. | 1988-04-13 | Traditional | PDF ↗ |
| K874981 | PRISMA DISPOSABLE J-SHAPED I/A CANNULA | Advanced Surgical Products, Inc. | 1988-04-13 | Traditional | PDF ↗ |
| K874974 | PRISMA DISPOSABLE SIMCOE CAPSULE POLISHER | Advanced Surgical Products, Inc. | 1988-04-13 | Traditional | PDF ↗ |
| K874990 | PRISMA DISPOSABLE SILICONE BULB | Advanced Surgical Products, Inc. | 1988-04-13 | Traditional | PDF ↗ |
| K874989 | PRISMA DISPOSABLE ADAPTER FOR IRRIGATORS | Advanced Surgical Products, Inc. | 1988-04-13 | Traditional | PDF ↗ |
| K875003 | PRISMA DISPOSABLE PUPIL CENTERING CANNULA | Advanced Surgical Products, Inc. | 1988-04-13 | Traditional | PDF ↗ |
| K874999 | PRISMA DISPOSABLE ATKINSON RETROBULBAR NEEDLE | Advanced Surgical Products, Inc. | 1988-04-13 | Traditional | PDF ↗ |
| K874982 | PRISMA DISPOSABLE SIMCOE EXTRACTOR | Advanced Surgical Products, Inc. | 1988-04-13 | Traditional | PDF ↗ |
| K874987 | PRISMA DISPOSABLE DOUBLE I/A CANNULA | Advanced Surgical Products, Inc. | 1988-04-13 | Traditional | PDF ↗ |
| K874973 | PRISMA DISPOSABLE SIMCOE I/A CANNULA | Advanced Surgical Products, Inc. | 1988-04-13 | Traditional | PDF ↗ |
| K874984 | PRISMA DISPOSABLE MICRO IRRIGATING VECTUS | Advanced Surgical Products, Inc. | 1988-04-13 | Traditional | PDF ↗ |
| K874971 | PRISMA DISPOSABLE PEARCE IRRIGATING VECTUS | Advanced Surgical Products, Inc. | 1988-04-13 | Traditional | PDF ↗ |
| K874970 | PRISMA DISPOS. TROUTMAN ALPHA-CHYMOTRYPSIN CANNULA | Advanced Surgical Products, Inc. | 1988-04-13 | Traditional | PDF ↗ |
| K874995 | PRISMA DISPOS. CURVED LACHRYMAL CANNULA | Advanced Surgical Products, Inc. | 1988-04-13 | Traditional | PDF ↗ |
| K874980 | PRISMA DISPOSABLE LEWICKY CHAMBER MAINTAINER | Advanced Surgical Products, Inc. | 1988-04-13 | Traditional | PDF ↗ |
| K874988 | PRISMA DISPOS. PEARCE IRRIGATING VECTUS W/ONE PORT | Advanced Surgical Products, Inc. | 1988-04-13 | Traditional | PDF ↗ |
| K874998 | PRISMA DISPOSABLE U-SHAPED CANNULA | Advanced Surgical Products, Inc. | 1988-04-13 | Traditional | PDF ↗ |
| K874978 | PRISMA DISPOSA. RYCROFT ANTERIOR CHAMBER CANNULA | Advanced Surgical Products, Inc. | 1988-04-13 | Traditional | PDF ↗ |
| K874986 | PRISMA DISPOSABLE RETROBULBAR NEEDLE | Advanced Surgical Products, Inc. | 1988-04-13 | Traditional | PDF ↗ |
| K874968 | PRISMA DISPOSABLE GILLS ANGLED I/A CANNULA | Advanced Surgical Products, Inc. | 1988-04-13 | Traditional | PDF ↗ |
| K874994 | PRISMA DISPOSABLE ANGLED I/A CANNULA | Advanced Surgical Products, Inc. | 1988-04-13 | Traditional | PDF ↗ |
| K874985 | PRISMA DISPOSABLE CAPSULE POLISHER | Advanced Surgical Products, Inc. | 1988-04-13 | Traditional | PDF ↗ |
| K873853 | DISPOSABLE INFUSION CANNULA 0045-1/2/3 2.5/4.0/6.0 | Advanced Surgical Products, Inc. | 1988-03-07 | Traditional | PDF ↗ |
| K873164 | VAN DELLEN HEALON CANNULA | Van Dellen, Ltd. | 1987-09-04 | Traditional | PDF ↗ |
| K873162 | VAN DELLEN RETROBULBAR NEEDLE | Van Dellen, Ltd. | 1987-09-04 | Traditional | PDF ↗ |
| K872884 | LOOK IRRIGATING/ASPIRATING CANNULA W/TEFLON SHEATH | Look, Inc. | 1987-08-10 | Traditional | PDF ↗ |
| K872610 | SOLOS EYESITE CANNULAS | Solos Ophthalmology | 1987-07-31 | Traditional | PDF ↗ |
| K872200 | HAMACHER BULLET POINT OPHTHALMIC NEEDLE | R. J. Doyle, Inc. | 1987-06-25 | Traditional | PDF ↗ |
| K871605 | MVS 2.5MM, 4.0MM, 6.0MM INFUSION CANNULA | Advanced Surgical Products, Inc. | 1987-06-19 | Traditional | PDF ↗ |
| K872151 | OPHTHALMIC CANNULA | Pharmacia, Inc. | 1987-06-19 | Traditional | PDF ↗ |
| K870902 | LOOK RETROBULBAR NEEDLES | Look, Inc. | 1987-03-20 | Traditional | PDF ↗ |
| K870438 | LOOK IRRIGATING CANNULAS | Look, Inc. | 1987-02-20 | Traditional | PDF ↗ |
| K870436 | LOOK IRRIGATING/ASPIRATING CANNULAS | Look, Inc. | 1987-02-20 | Traditional | PDF ↗ |
| K870441 | LOOK CORTEX EXTRACTORS | Look, Inc. | 1987-02-20 | Traditional | PDF ↗ |
| K861545 | IRRIGATION/ASPIRATION CANNULAS, VARIOUS SIZES | Rophae Lens Co., Inc. | 1986-05-28 | Traditional | PDF ↗ |
| K860744 | OPTHALMIC SURGICAL INSTRUMENTS | Tridak Division of Indicon, Inc. | 1986-03-31 | Traditional | PDF ↗ |
| K854506 | STORZ MVS 2.5MM/4.0MM,6.0MM INFUSION CANNULA | Storz Instrument Co. | 1986-02-07 | Traditional | PDF ↗ |
| K854401 | THE NEW MOBILE TIP MCINTYRE CANNULA | Microsurgical Technology, Inc. | 1985-12-30 | Traditional | PDF ↗ |
| K854402 | THE NEW MCINTYRE I.A. HANDPIECE | Microsurgical Technology, Inc. | 1985-12-30 | Traditional | PDF ↗ |
| K853777 | THE NEW MCINTYRE CANNULA | Microsurgical Technology, Inc. | 1985-11-21 | Traditional | PDF ↗ |
| K852758 | INFUSION CANNULAM | Precision Medical Instruments, Inc. | 1985-08-01 | Traditional | PDF ↗ |
| K843039 | SITE ANTERIOR CAPSULOTOMER | Chiron Vision Corp. | 1984-11-21 | Traditional | PDF ↗ |
| K840442 | STERILIZED DISPOS. CYSTOTOME | Microsurgical Technology, Inc. | 1984-03-16 | Traditional | PDF ↗ |
| K831532 | OCULAR IRRIGATING CANNULA | Dey Laboratories, Inc. | 1983-07-12 | Traditional | PDF ↗ |
| K831192 | INFUSION CANNULA | Medical Instrument Development Laboratories, Inc. | 1983-06-30 | Traditional | PDF ↗ |
| K813314 | NLD IMPLANT SET | Design Research Assoc., Inc. | 1982-02-24 | Traditional | PDF ↗ |
| K813481 | OMS INFUSION CANNULA ASSEMBLE | Optical Micro Systems, Inc. | 1982-01-22 | Traditional | PDF ↗ |
| K812010 | KOI LACRIMAL INTUBATION SYSTEM | Koi, Inc. | 1981-07-28 | Traditional | PDF ↗ |
| K811455 | ANIS GUIDING CANNULA | American V. Mueller | 1981-06-16 | Traditional | PDF ↗ |
| K801411 | MAY ILLUMINATED/INFUSION PIC | Cooper Medical Devices Corp. | 1980-07-21 | Traditional | PDF ↗ |
| K791917 | X-PAK | Contemporary Surgical Systems, Inc. | 1979-10-30 | Traditional | PDF ↗ |
| K791982 | CANNULA'S CAT #'S 6636, 6624, 6625 | Edward Weck, Inc. | 1979-10-04 | Traditional | PDF ↗ |
| K782169 | NEEDLES, CANNULAS, CYSTOTOMES | Visitec Co. | 1979-02-13 | Traditional | PDF ↗ |
| K790243 | CANNULAS | Visitec Co. | 1979-02-12 | Traditional | PDF ↗ |
| K771416 | IRRIGATION/ASPIRATION NEEDLE | Concept, Inc. | 1977-09-12 | Traditional | PDF ↗ |
Product code HMX · Class I · Ophthalmic. Data: openFDA.